Intended use/General information
Our equipment complies with the requirem ents of standards for medical products (MPG) and Directive 93/42/EEC for Medical Devices,
revised by EU-Directive 2007/47/EG from 2010-03-21.
It complies with the VDE-requirements for electromedical devices DIN EN 60601, part 1 / DIN VDE 0750, part 1, too. It is suited
for connection to supply lines installed according to the DIN VDE 0100-710 regulations for medically used rooms.
Intended use
This dental treatment unit is used for dental treatment in humans by qualified personnel.
Warnings
This unit is not explosion-proof.
This dental treatment unit must not be modified without permission of the manufacturer.
We can only accept responsibility for the safety properties of our equipment, if installation, maintenance, repair
and modifications are carried out by our workshop or by a person explicitly authorized by us. Further, the
equipment has to be correctly handled according to our operating manual.
In case of failure, structural parts, that can affect the security of the device, are to be replaced by original parts
only.
In case of repair, the technician must issue a certificate as to the kind and extent of work performed and, if
applicable, indicate any changes of nominal data and operating range. The certificate must contain the date of
repair, the name of the executing company and a signature (according to MPG, DIN VDE 0750 / DIN VDE 0751).
Close to the equipment do not operate any devices producing electro-magnetic emissions (such as wire-less
phones, micro-wave therapeutics devices,...)
Safety-relevant inspections
The safety standards for medical products and all legal obligations are to be fully observed by the user.
Scope and schedules of safety-relevant inspections are as follows:
Every two years the following safety-relevant inspections according to DIN EN ISO 62353 have to be performed:
see Form „Safty inspections – Dental treatment unit".
We recommend to keep an equipment control log for documenting the results of the safety-relevant inspections.
The unit lifetime cycle is: 10 years.
Operator (intended user)
The user must have a completed medical training (study), specializing in dental, or have comparable field of
study.
Multimedia
For components like Intraoral camera, monitor, note the separate user manuals for these devices !
Disposal
According to law, electric equipment is to be disposed by authorized disposal firms only.
10 General
Ultimate Comfort Smart
© Ritter Concept GmbH
C20-0094-1801EN-ES
